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FDA Analysis Suggests Potential Pituitary Tumor Signal For Risperdal

This article was originally published in The Pink Sheet Daily

17 Jun 2005

News

Andrew Shelton

Executive Summary

Review of adverse event reporting system of pituitary tumors and antipsychotics shows the “vast majority” of tumors were with risperidone. Further data is needed before the signal would be posted on FDA’s drug safety watch list, the agency says. J&J will analyze the study and other data to determine if further studies are needed.